BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18649448 · Received February 6, 2024

    Report

    Report Number
    2210968-2024-00983
    Event Type
    Injury
    Date Received
    February 6, 2024
    Date of Event
    May 13, 2020
    Report Date
    February 9, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. CITATION: ANN VASE SURG 2020; 68: 549-552, HTTPS://DOI.ORG/10.1016/J.AVSG.2020.04.044.

    Description of Event or Problem · 0

    TITLE: A TECHNICAL TIP OF AORTIC STUMP REINFORCEMENT WITH PLICATION OF THE FALCIFORM LIGAMENT OF THE LIVER. THIS STUDY PRESENTS AN INNOVATIVE TECHNIQUE IN WHICH THE FALCIFORM LIGAMENT OF THE LIVER WAS USED TO REINFORCE THE AORTIC STUMP. THIS REPORTS A CASE OF 66-YEAR-OLD MAN PRESENTED TO THE EMERGENCY DEPARTMENT WITH FEVER, LEUKOCYTOSIS, AND HEMATOCHEZIA. THE PATIENT HAD UNDERGONE OPEN RECONSTRUCTION FOR AN ABDOMINAL AORTIC ANEURYSM WITH ANEURYSMATECTOMY AND AN AORTOBIILIAC BYPASS WITH A POLYESTER GRAFT 6 MONTHS EARLIER. THE PATIENT WAS TREATED WITH EXCISION OF THE WHOLE GRAFT AND CLOSURE OF THE AORTIC STUMP AND AXILLOBIFEMORAL BYPASS. THE DUODENAL LESION WAS TREATED WITH GASTROENTERIC BYPASS AND PYLORIC LIGATION. THE AORTIC STUMP WAS VERY STIFF BECAUSE OF THE LOCAL BACTERIAL INFECTION AND THE LIGATION OF THE INFRARENAL AORTA WAS DIFFICULT. MULTIPLE PROLENE 3-0 AND 2-0 SUTURES (ETHICON) WITH A STIFF NEEDLE WERE APPLIED TO PARTIALLY PLICATE THE AORTIC STUMP, WHICH WAS VERY STIFF BECAUSE OF THE LOCAL BACTERIAL INFECTION. IN ADDITION, AN OMENTAL WRAP WAS SECURED AROUND THE STUMP AND AROUND THE AREA AFTER COMPLETE GRAFT REMOVAL. THE PATIENT WAS DISCHARGED 15 DAYS AFTER THE SURGERY AFEBRILE WITH ORAL ANTIBIOTICS AND IN MODERATE CLINICAL CONDITION. 21 DAYS LATER, THE PATIENT WAS READMITTED AFEBRILE WITH THORACIC PAIN WHICH WAS ATTRIBUTED TO HEART ISCHEMIA. THE PATIENT PRESENTED MASSIVE UPPER GASTROINTESTINAL BLEEDING. AN ESOPHAGOGASTRODUODENOSCOPY SHOWED THAT THE LESION IN THE THIRD PORTION OF DUODENUM HAD NOT BEEN HEALED WITH THE PRESENCE OF FRESH THROMBUS AND NO ACTIVE BLEEDING. A CTANGIO DID NOT REVEAL ACTIVE EXTRAVASATION OF BLOOD FROM THE AORTIC STUMP BUT POSED THE SUSPICION OF BLEEDING THROUGH A GUTTER OF THE AORTIC STUMP IN THE DUODENUM. AFTER 2 DAYS, RESECTION OF THE THIRD AND FOURTH PART OF DUODENUM AND SIDE-TO-SIDE ROUX-EN-Y DUODENOJEJUNOSTOMY WAS PERFORMED. PURULENCE IN THE AORTIC STUMP OR ACTIVE BLEEDING WAS NOT FOUND. HOWEVER, THE SUTURES OF THE AORTIC STUMP WAS FOUND TO BE LOOSE. THE AORTIC STUMP WAS REINFORCED WITH PROLENE 3-0 SUTURES (ETHICON), AND THE FALCIFORM LIGAMENT OF THE LIVER WAS PLICATED INSIDE THE STUMP AND FURTHER SUTURED WITH PROLENE 3-0 (ETHICON). THE PATIENT WAS PROGRESSIVELY FED. POSTOPERATIVELY, HE PRESENTED HYPOXIC ISCHEMIC ENCEPHALOPATHY WHICH WAS TREATED CONSERVATIVELY NOT LEAVING ANY NEUROLOGICAL DEFICIT AND WAS DISCHARGED AFTER 40 DAYS WITH ANTIPLATELET AND ANTIBIOTIC THERAPY. AFTER 5 MONTHS, HE IS IN EXCELLENT CONDITION. HIS LABORATORY EXAMINATION IS NORMAL, HE HAS STOPPED TAKING ANTIBIOTICS, GAINED HIS INITIAL WEIGHT, AND RECOVERED FULL ACTIVITY. REPORTED COMPLICATION INCLUDED LOOSE SUTURES IN THE AORTIC STUMP (N=1). IN CONCLUSION, WE PRESENTED AN INNOVATIVE TECHNIQUE IN WHICH WE USED THE FALCIFORM LIGAMENT OF THE LIVER TO REINFORCE THE AORTIC STUMP AFTER EXCISION OF AN INFECTED AORTOBIILIAC SYNTHETIC GRAFT. THIS TECHNIQUE CAN BE AN ALTERNATIVE OPTION IN PATIENTS WITH WEAK ARTERIAL WALL OR EXTENDED BACTERIAL LOCAL INFECTION IN THE RETROPERITONEAL AREA WHICH RENDERS THE AORTIC WALL TISSUE EXTREMELY STIFF TO BE FOLDED AND SUTURED. THIS TECHNIQUE MAY ENHANCE THE MECHANICAL INTEGRITY OF THE STUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496600 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention